Amylyx Pharmaceuticals, Inc.

Good afternoon. My name is Tom, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals second quarter 2023 earnings conference call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, please press star, then 1 on your telephone keypad. And to withdraw yourself from the question queue, please press star, then 2. Please be advised that this call is being recorded at the company's request. I would now like to turn the conference over to Lindsay Allen, Head of Investor Relations and Communications. Please go ahead.

Good afternoon, and thank you for joining us today to discuss our second quarter 2023 earnings. With me on the call are Josh Cohen and Justin Klee, our co-CEOs, Margaret Olinger, our Chief Commercial Officer, and Jim Friedes, our Chief Financial Officer. Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are made based on our current beliefs, plans, and expectations and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our expectations with respect to Livrio and Albreoza, statements regarding our clinical trials and regulatory developments and the expected timing thereof, our business strategy and outlook, and our expected financial performance. Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors. including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. You are cautioned not to place any undue reliance on these forward-looking statements, and Amilex disclaims any obligations to update such statements unless required by law. Now, I will turn the call over to Justin.

Thank you, Lindsay, and good afternoon. In the second quarter, we made significant progress in bringing Relivrio and Albreoza to people with ALS in the U.S. and Canada, respectively, and advancing our mission of one day ending the suffering caused by ALS and other neurodegenerative diseases. We are incredibly proud of our entire team who has continued to deliver on the goals that we outlined following the full FDA approval of Relivrio last September. These goals included raising awareness and educating people living with ALS and physicians about Relivrio, working with insurers to provide access to our approved treatment, helping people who have been prescribed Relivrio through our AMLEX Care Team Patient Support Program, and deepening our understanding of the ALS market. Let me walk you through our progress. Our commercial organization is off to a strong start educating and raising awareness about Relivrio. as evidenced by the strong and steady demand we saw in the second quarter. As of June 30, 2023, there were roughly 3,800 people on Relivrio in the U.S., up from roughly 3,000 people on Relivrio as of March 31, 2023, and just over 1,300 at the end of 2022. As for insurance coverage, adoption has been rapid, and a vast majority of policies have been broad and supportive. Insurers covering nearly all people living with ALS have published formal policies and are covering Relivrio. And people living with ALS that have been prescribed Relivrio are now able to start therapy more quickly. The average time between a prescription being written and Relivrio being shipped was about 25 days in the second quarter, down from around 30 days in the first quarter of this year and a little over 45 days when we shared this metric on our fourth quarter earnings call. Turning to Canada, we reached our one-year anniversary of the Health Canada approval with conditions in June. As we reflect on our progress, we are pleased with what we have achieved on behalf of the Canadian ALS community. In the fourth quarter of last year, we announced that all major private insurers in Canada covered Albreoza, and we are pleased to share today that by the end of August, We expect Albreoza coverage to be in place for the vast majority of publicly insured lives in Canada. The early success of our commercial launches has enabled us to both invest in bringing Relivrio to more people living with ALS globally and advance our pipeline opportunities that support our mission. We continue to expect a final opinion on our MAA from CHMP in the fall and prepare to execute a successful launch in the EU if approved. We are excited to initiate our new phase three Orion clinical trial of AMX 35 in progressive supernuclear palsy later this year. And of course, we continue to work diligently to complete the Phoenix trial with top line results anticipated in mid 2024. In summary, we are proud of our progress so far in 2023 and excited about what we can achieve as an organization. We have a clear mission and we are executing on our goals. I'll now turn the call over to Margaret to provide an update on our commercial performance.